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Perfusion Pack (UDI 00803622110375)Recalls & reported problems

Livanova USA, Inc.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00803622110375), received between Aug 30, 2018 and Aug 30, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Fragmentation1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 30, 2018Material Fragmentation; Material Fragmentation

    LIVANOVA RECEIVED A REPORT THAT A METAL FLAKE ORIGINATING FROM THE STAINLESS STEEL COIL WAS OBSERVED IN THE TUBING OF THE CUSTOM PERFUSION TUBING SET DURING PRIMING. A CARDIOPLEGIA LINE ASSEMBLY WAS PULLED FROM ANOTHER PACK TO BEGIN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 7833030 ↗

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.